Periodic Reporting for period 1 - ADHESION (Development of new biotech AdvanceD materials based on Hyaluronic acid and nanoparticlEs to prevent Surgical adhesIons and pOst surgical infectionNs) Reporting period: 2015-05-01 to 2015-10-31 Summary of the context and overall objectives of the project The aim of this proposal is to create a new post-surgery membrane targeted to the orthopaedic, cardiology and abdominal/pelvic surgery. This device, based on a proprietary product (DAC®) and presented in a modified physical form (i.e. lyophilized), will be obtained through the addition of an optimal combination of ascorbate and/or silver citrate. The new device will have enhanced anti-adhesive, anti-bacterial and stability performances, resulting in a more competitive solution.Adhesion is a major post-surgical complication showing about 100% incidence, with a complication rate of 3-8%, depending on surgery type. Concurrently, an increasing menace to health is due to the insurgence of bacterial infections in hospitals, with incidence around 10% of the patients.NOVAGENIT® intends to address both the adhesion and infection issues. Specifically the business opportunity consists in the combination of the three key features (anti-fouling, antibiotic and usability) into a novel product not yet available on the market, and to target three surgery markets (abdominal/pelvic, cardiology and orthopaedic) in order to generate the appropriate return of the investment. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far NOVAGENIT® performed a technological and commercial feasibility analysis for the development of an anti-adhesion and anti-bacterial post-surgery lyophilized membrane. Activities performed:1. Standardization of the Manufacturing Process for lyophilized HA-PLA, including the activity carried out to select the viscosity as the most representative parameter of its stability.2. Stability testing at accelerated conditions (25°C) of lyophilized HA-PLA irradiated at 25kGy showed stability after 6 months with respect to viscosity control parameter; since experiments were carried out on a single lot, additional tests are needed in phase2 to corroborate the results.3. Anti-bacterial tests have confirmed the efficacy of lyophilized HA-PLA supplemented with Vitamin C against 4 main pathologic strains. NOVAGENIT® will confirm during phase 2 these results on a wider sample, challenging the new formulation with various pathogenic bacterial families. The tests performed on metallic nanoparticles, including silver, have not shown positive results thus leading to the decision to focus on silver citrate during phase2.4. According to the commercial feasibility analysis, NOVAGENIT® has run a btm-up survey on 41 surgeons. The survey has confirmed that the identified key product’s characteristics fit to the customers’ needs.5. Analysts’ report on the WW anti-adhesion market confirms the market to grow from 1.4B$ in 2014 to 2.2B$ in 2020, with a CAGR of 7,8%.6. NOVAGENIT® has built a business plan, considering the market price for equivalent products, the expected manufacturing unit cost and the sales forecast over 3 years following the completion of the project. The business plan shows positive cash flow and ROI prospects. Comparing NOVAGENIT® sales forecast with the TAM, the company is expected to outperform the market over the forecast period, with steady market share growth till 2020.7. The commercial feasibility analysis has also identified a path towards the enlargement of the sales channel, in order to extend the commercialization from the orthopaedic to the cardiovascular and abdominal/pelvic segments, markets keen on value both the anti-bacterial and anti-adhesion product performances. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) NOVAGENIT® is expecting to introduce a competitive brand new portfolio and enlarge its market coverage. This project will result in an incremental turnover exceeding 5M€ within 3 years from the commercialization, with positive ROI and double digit market share increase. This will also result in 10 additional resources to be hired during the commercialization phase.In addition to the specific NOVAGENIT® expected results, other stakeholders will also benefit from the project foreground:• patients, who need to reduce the risks of infections, adherences and recurrent operations,• healthcare system, who have to reduce the costs of re-hospitalization due to after surgery complications.In conclusion ADHESION can be a perfect vehicle for a change of mind-set among the surgeons and the healthcare decision makers, in order to introduce easily adoptable preventive procedures able to significantly reduce the incidence of complications, alleviate the discomfort for the patients, optimise the healthcare costs thanks to the re-interventions reductions, and ultimately improve the quality of life. DAC membrane during re-hydration to become a gel DAC membrane after lypophilization
